European market, EC-marked displays based on compliance with counsel directive 93/42/EEC
— commonly referred to as the Medical Device Directive (MDD).The following summarizes
our qualification of these displays as it relates to compliance with the MDD.
The European MDD requires that the intended use of the device be defined.The intended use
of the Invitium workstation is “to display alphanumeric, graphic, and image data as inputted
from any type of medical device.”This system does not provide a measurement function in any
way, and it is the device and systems manufacturers responsibility to verify its function in the
integrated device or system.The workstation was classified as required by the MDD according
to Annex IX of the directive and the medical device (MEDDEV) guidance available at the time
of classification.
Because the workstation uses electrical energy and has no direct patient connections and- — by
itself — no medical utility, the workstation is classified according to Rule 12 as an MDD Class I
device-component or accessory.
The MDD states that manufacturers of Class I medical devices or accessories shall satisfy the
requirements in regard to design and manufacturing controls; i.e., the applicable assessment
route to be used for CD-marking under the MDD, and it shall carry the CD-mark according to
Annex XII for the directive, with no notified body annotation.
The applicable safety standards for an MDD Class I device are IEC/EN60601-1: 1990 along
with Amendments 1 and 2.To help the medical device designer evaluate the suitability of these
workstations, Planar has also conducted EMC testing to IEC 60601-1-2 as it can be applied.
The display with its power supply alone does not represent a functional medical device. Hence,
Planar configured a minimal operating system to exercise the display.The resulting data is made
available to interested parties.
The data is informative data, not certification data. Certification data must be obtained by the
device or system integrator according to Article 12 of the MDD titled “Particular procedure for
systems and procedure packs.” Paragraph 2 clearly outlines the device or system integrator’s
responsibility in this matter.
In summary, Planar Systems, Inc. is CE-marking theses workstations under the Medical Device
Directive, which establishes compliance to the basic medical safety standards. However, EMC
compliance can only be accomplished in the configured medical device or system and is the
responsibility of the device or system manufacturer. Planar has the necessary documentation
such as IEC 60601-1 notified body and other third-party test reports and certifications, a
risk/hazard analysis, and essential requirements checklist, and Planar’s International
Electrotechnical Commission (IEC) declaration of conformity.
Planar Systems, Inc. located in Beaverton, OR, USA is the manufacturer of these workstations
in the meaning of the directive. As required by the MDD in Article 14, Planar Systems, Inc. not
residing in the European Economic Area (EEA) has a European Representative, Planar Systems,
Inc. –Espoo, Finland.
In the opinion of Planar Systems, Inc. registration required to put its device into commerce is
the responsibility of the medical device/system manufacturer, and Planar supports this require-
ment by providing a European Commission (EC) declaration of conformity. If Planar supplies a
workstation to an end user, rather than a device manufacturer, it is the end user’s responsibility
to ensure continued compliance with the MDD of the system in which the workstation is inte-
Introduction
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